Home / 510(k) Clearances / K760838

510(k) K760838

LACTO-PHENOL COTTON BLUE MOUNTING FL. by I M, Inc. — Product Code LEB

K760838 is an FDA 510(k) premarket notification submitted by I M, Inc. for the device "LACTO-PHENOL COTTON BLUE MOUNTING FL.". The FDA issued a decision of Substantially Equivalent on November 16, 1976. The device falls under product code LEB (Mounting Media), a Class I device regulated under 21 CFR 864.4010. I M, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1976
Date Received
October 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mounting Media
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by I M, Inc.

  • K914600 — NEUROLOGICAL SPONGE (December 30, 1992)
  • K892389 — BIOPSY KIT (July 17, 1989)
  • K881363 — SYRINGE PREFILLED WITH WATER (June 23, 1988)
  • K880753 — UMBILICAL CORD CLAMP (April 27, 1988)
  • K872741 — NUTRIPUMP (October 20, 1987)
  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
  • K853287 — HUBOUT (October 17, 1985)
  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

Other clearances for product code LEB

  • K842986 — REFRAX MOUNTING MEDIUM (August 21, 1984)
  • K821019 — PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU (April 26, 1982)
  • K812193 — KOH MOUNTING FLUID (August 31, 1981)
  • K811799 — CLEAR-MOUNT (July 31, 1981)

FDA data resources